Process Validation For Medical Devices – NUS - NUSAGE ...

National University of Singapore Academy of GxP Excellence (NUSAGE)
and PharmEng Technology Presents
Process Validation for Medical Devices
Part of the Pharmaceutical and Biotechnology Training Courses
Instructor
Kenny Peng
* Instructor may be subject to change
due to unforeseeable circumstances.
In case of a change, updated
instructor profile will be made
available to the organizer and the
attendees.
Date and Time
22-23 November 2012
9 AM – 5 PM
Location
Global Classroom
Department of Pharmacy
National University of Singapore
S4 Level 5
18 Science Drive 4
Singapore 117543
Tel: 65162647 / 8
Fax: 67791554
Website: www.NUSAGE.nus.edu.sg
Location:
Please view NUS interactive campus map at
http://www.nus.edu.sg/campusmap/, look under Science, Department
of Pharmacy.
By taxi/foot:
Please turn into and drive/walk along Science Drive 4, then go under
building with "Fire ENGINE ACCESS" sign. Go straight down to loading
bay where S4 building will be right in front.
By car:
Please park at the Visitors' lots inside University Hall (Tan Chin Tuan
Wing), Carpark 6B along Lower Kent Ridge Road just next to Science
Drive 4.Then walk through level 2 of Lee Kong Chian Wing towards
Science Drive 4, and walk along to reach S4 as per above.
To Library: Please proceed to S4 Level 2
To Pharmacy Global Classroom: Please proceed to S4 Level 5
NUSAGE- PharmEng 2011 Professional Training Program

NUSAGE- PharmEng 2012 Professional Training Program
Process Validation for Medical Devices
Objective
The objective of this course is to provide an introduction to the fundamentals of process
validation, explaining how, when, where and why you should validate. Participants will learn
more how to comply with FDA and international regulations for validation protocols. Also
included is comparison of major global medical device regulations and updates of US, EU,
Canada, A.S.E.A.N, Japan and Singapore.
Description
The FDA guideline on “General Principles of Process Validation” was first issued in May,
1987, and since then, medical device companies have struggled with the principles of
process validation as much of the industry focused on pharmaceutical processes. A
successful validated process may result in a reduced time to market for new products. Using
the tools developed in this course participants will be able to methodically plan and conduct
a process validation for medical devices.
Course Outline
• Introduction
• Purpose and scope
• Process Validation Terminology
• Introduction to Process Validation - Process validation requirements
o Requirements of 21 CFR Part 820.75
o Requirements of ISO 13485:2003 and ISO 14971:2007
o Recommendations of GHTF N99-10
o Difference between validation and verification
o Types of validation (i.e. Prospective, Concurrent and Retrospective Validation)
• Implementing a Process Validation System - Elements of process validation
o Master Validation Plan (MVP)
o Installation, Operation, and Performance Qualification (IQ, OQ, PQ)
o Application of risk management to process validation
• Executing a Validation
o Process validation steps
o Validation protocol design and final report
o Cleaning Validation
• Maintaining a state of validation
o Monitor and control
o Changes in process and/or product
o Continued state of control
• Comparing Medical Device Regulations and Updates of EU, US, Canada, ASEAN, Japan
and Singapore
About the Trainer
Kenny Peng, RAC, P.Eng., is
Director, Asia, for PharmEng
Technology. Kenny is a licesned
professional engineer (Canada), a
certified regulatory affairs
professional, and consults
professionally in the Asia-Pacific
region. Kenny graduated with a
Masters degree in Engineering from
the University of Waterloo,
Canada. His early career began
with research work during
university years in biomaterials
(University of Toronto) and in
nonlinear mechatronic systems
(University of Waterloo), where
some of the technologies have
since been successfully
commercialized. His subsequent
consulting career began with the
design and engineering of
pharmaceutical manufacturing
equipment and facilities in North
America, which led to the
commissioning/qualification/valida
tion of pharmaceutical and medical
device manufacturing facilities and
processes. Since 2008, Kenny has
successfully assisted medical
devices companies across Asia
through 5 US FDA audits, as well as
numerous ISO audits. Today, his
work involves start-up, technology
transfer, regulatory affairs,
validation, and engineering for
pharmaceutical and medical device
companies across Southeast and
Northeast Asia. Kenny is a native
speaker/writer in English and
Chinese.
Who should attend and what the participants will learn from the course
This two-day course is targeted toward professionals directly involved in meeting the
international and FDA’S Quality System Validation requirements. This includes
professionals in regulatory affairs, quality assurance, process development or
manufacturing. This course provides regulatory/quality systems professionals,
manufacturing engineering, and process development engineers with the knowledge and
skills needed to comply with the process validation requirements of the FDA’s Quality
System Regulation, ISO 13485 and GHTF Validation guidance N99-10. The course is also
intended for Medical Device professionals who are responsible for performing process
validation studies and ensuring compliance with regulatory requirements for validation
documentation.

NUSAGE- PharmEng 2012 Professional Training Program
Process Validation for Medical Devices
Registration Form
Please Print or Type Clearly
Full Name & Title* (Prof/Dr/Mr/Mdm/Ms)
Job Title
% Knowledge on Subject Matter
Company
Business Address
Business Tel
Mobile No.
E-mail Address
Special Diet* ( Non-spicy / Vegetarian / Vegetarian w/o egg / No beef / Halal )
* Delete where appropriate
Fees:
S$1070 per delegate after GST.
Early bird discount 14 calendar days before the
course / group discount of 5 or more delegates:
10% off per delegate ($963 after GST)
Course Fees includes course materials, tea breaks
and lunch.
Please return completed forms by mail/fax to:
NUSAGE
National University of Singapore
Department of Pharmacy
S4, Level 2
18 Science Drive 4
Singapore 117543
Email: phacyj@nus.edu.sg,
DID: 65165878
Fax: 67791554
Payment:
Only cheques in SGD$ are accepted. Please make
cheques payable to:“National University of Singapore”
If invoice is required, please write to phacyj@nus.edu.sg
with full billing and contact details.
Payments must be received at least one week prior to
event.
Cancellations must be made in writing. If cancellations
are received 2 weeks prior to course, a full refund,
minus a handling fee of $75 will be issued. No refunds
will be granted thereafter. Substitutions are acceptable
if the registrant is not able to attend.
Registered participants will be informed in case of postponement
or cancellation due to unforeseen circumstances, and any
payments received will be refunded.

About the Training Provider
PharmEng Technology (“PharmEng”), a division of PEPharma Inc., provides professional
development and certification training programs throughout North America and Asia.
We deliver over 35 courses to the pharmaceutical, biotechnology, nutraceutical and
medical devices industries in the areas of:
• cGMPs
• Validation
• Engineering
• Project Management
• Medical Devices
• Quality Compliance
• Quality Assurance
• Regulatory Affairs
• Manufacturing
Best instructor and best coverage of
this subject that I’ve experienced yet.
Great session – so glad I came.” IMRIS
Inc.
“… good course, especially the case
studies.” Genesys Venture Inc.
“It was a nice change that the
instructor had personal experience that
I could relate to.” Medicure Inc.
Why PharmEng Professional Training
Unique curriculum that covers key areas critical to the success of the industry, through
courses that integrate theory and practice.
Advisory committee that includes members from industry, academia and government,
ensuring that important regulatory and industry issues are addressed.
Custom courses that cover both general and basic “know-how” as well as current
challenges, issues and new developments in the industry.
Instructors that have been selected among industry leaders and subject experts who will
provide challenging course work and valuable hands-on experience.
PharmEng delivers courses to two distinct groups:
1. Corporate Training: Experienced industry professionals who require current best
practices in order to keep up-to-date with industry standards, Good Manufacturing
Practices (GMP’s) and regulations.
2. Career Training: Next generation individuals seeking careers in the industry who
need practical skills and “know-how” for the pharmaceutical and biotechnology
workforce.
For those individuals requiring one day professional development programs, courses are
available through any of the PharmEng offices located throughout North America and
Asia with access to course listings, course availability and registration through the
PharmEng website www.pharmeng.com.
Certification Programs
For career training and certification, PharmEng offers programs through national and
internationally-recognized universities delivering certificate programs such as:
The Biopharmaceutical Technology Certificate Program for the University of Waterloo
and the National Tsing Hua University College of Life Science in Taiwan
The Biotechnology and Pharmaceutical Technology Program for Cape Breton University
Instructors and Course Materials
All instructors are subject matter experts with direct industry experience. Instructors
include guest speakers from industry, government and academia. Course materials are
developed by PharmEng in-house and are constantly updated to keep current with the
regulatory environment. As the industry changes, so do the issues and challenges. Our
courses, with supporting materials, link together:
• Training
• Regulations
• Government
• Industry
• Academia
• International Standards
Conferences
PharmEng offers conferences throughout the year in collaboration with Health Canada,
and various professional associations in biotechnology, pharmaceutical, medical devices,
nutraceutical and healthcare industries.

About the Training Provider
PHARMENG CORE TRAINING COURSES
Current Good Manufacturing Practices
• GMP – Get More Productivity
• GMP – Concepts and Implementation
• cGMP’s for Drugs and Active
Pharmaceutical Ingredients
Manufacturers
cGMP training is tailored to meet your
company’s specific needs in one or all of
the following areas:
• Engineering
• Production
• Packaging
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Clinical Research
• New Drug Submission/Application
• Natural Health Products
• Active Pharmaceutical Ingredients
• Medical Devices
• Blood and Blood Products
• Practical cGMP
Engineering
• Commissioning and Validation of
Pharmaceutical and Biotechnology
Facilities
• Design and Validation of Critical Utility
Systems
• Process Analytical Technology (PAT)
• Design and Commissioning and
Validation of
• Pharmaceutical and Biotechnology
Facilities
Quality and Compliance
PharmEng® also provides customized
Good Laboratory Practices (GLP) and
Good Clinical Practices (GCP) training to
clients in order to assist companies in
moving forward with their pre-clinical
and clinical trials.
• Master Plan – Roadmap to Compliance
• Good Laboratory Practices (GLP)
• Pharmaceutical Quality Assurance and
Control
• GMP Programs – Planning and
Implementation
• Audit Programs and Annual Review
• Recall and Compliant Systems
• Standard Operating Procedures
• Corrective and Preventative Actions
(CAPA)
• Risk-based Approach to Inspecting
Quality Systems
Validation
• Analytical Methods Validation
• Process Validation
• Cleaning Validation
• Computer Systems Validation
• Validation of Sterilization Processes
Project Management
• Project Management in a Regulatory
Environment
• Project Management for Clinical
Research Studies
Medical Devices
• Medical Device Regulatory
Requirements
• Quality System Requirements – ISO
13485
• Quality Systems for Medical Devices
Manufacturing
• Manufacturing Control in the
Pharmaceutical Related Industries
• Pharmaceutical and Biotech
Manufacturing Processes
• Active Pharmaceutical Manufacturing
• Solid and Semi-Solid Dosage
Manufacturing
• Aseptic Manufacturing
• Sterile and Septic Processes
Regulatory Affairs
• Good Clinical Practices (GCP)
• New Drug Application/Submission
• Chemistry, Manufacturing and Control
• Natural Health Products Registration
PharmEng Technology, a division of PE Pharma Inc.,
headquartered in Toronto, Canada, is a full-service
consulting company that serves the pharmaceutical and
biotechnology industries internationally. Consulting
services include project management, engineering, cGMP,
validation, calibration, regulatory compliance and
certified training.